Clinical Regulatory Writer, Associate Director
Company: AstraZeneca
Location: Montgomery Village
Posted on: February 18, 2026
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Job Description:
Location: Gaithesrburg, MD- Hybrid (3 days onsite) Introduction
to role: Are you ready to be part of the solution, turning drug
development strategies into reality? As an Associate Director in
Clinical Regulatory Writing, youll play a pivotal role in
translating life-changing science into medicines. Our team provides
expert communications leadership to drug projects, authoring
strategically important clinical-regulatory documents that align
with project strategies and regulatory requirements. We support
AstraZeneca’s core therapeutic areas across all phases of clinical
development, striving for excellence in communication to achieve
successful submissions and approvals. Accountabilities: As a
Clinical Regulatory Writer, Associate Director, you will:
Independently manage clinical regulatory writing activities across
a complex portfolio of work. Author the most complex
clinical-regulatory documents within a program, ensuring
regulatory, technical, and quality standards are met. Provide
strategic communications leadership to projects, establishing
communication standards and advocating for quality and efficiency.
Drive the development of the clinical Submission Communication
Strategy (cSCS) when acting as a submission lead. Lead
internal/external authoring teams and partner with vendor medical
writers to ensure timely and quality delivery. Interpret complex
data and information, condensing it into clear, concise messages
that meet customer information requirements. Demonstrate strategic
thinking and review capabilities. Collaborate proactively with
other functions at the program level. Support the development of
Clinical Regulatory Writing Managers. Drive continuous improvement
and operational excellence from a communications leadership
perspective. Essential Skills/Experience: BS Life Sciences degree
in an appropriate discipline. Significant (7 yrs) medical writing
experience in the pharmaceutical industry or CRO. Ability to advise
and lead communication projects. Understand drug development and
communication process from development, launch through life cycle
management. In-depth knowledge of the technical and regulatory
requirements related to the role. Desirable Skills/Experience:
Advanced degree in a scientific discipline (Ph.D.) This is a Hybrid
role - minimum requirment 3 days per week onsite When we put
unexpected teams in the same room, we unleash bold thinking with
the power to inspire life-changing medicines. In-person working
gives us the platform we need to connect, work at pace and
challenge perceptions. Thats why we work, on average, a minimum of
three days per week from the office. But that doesnt mean were not
flexible. We balance the expectation of being in the office while
respecting individual flexibility. Join us in our unique and
ambitious world. AstraZeneca is where innovation meets
collaboration. We harness diverse knowledge to move with agility,
working seamlessly across functions globally. Our team is empowered
to make quick decisions, influencing drug development strategy at
all levels. With a science-driven approach, we bring life-changing
medicines to patients, constantly asking questions and trying new
things. Your professional growth is passionately supported here,
with opportunities to work on projects at all stages of
development. Ready to make an impact? Apply now and be part of our
dynamic team! The annual base pay (or hourly rate of compensation)
for this position ranges from $133,042.40 - $199,563.60 USD Annual.
Our positions offer eligibility for various incentives—an
opportunity to receive short-term incentive bonuses, equity-based
awards for salaried roles and commissions for sales roles. Benefits
offered include qualified retirement programs, paid time off (i.e.,
vacation, holiday, and leaves), as well as health, dental, and
vision coverage in accordance with the terms of the applicable
plans.
Keywords: AstraZeneca, Dale City , Clinical Regulatory Writer, Associate Director, Science, Research & Development , Montgomery Village, Virginia
